Agency classClass IIOur severity:Severe FDA (Devices)·Z-0953-2015·Announced 2015-01-21

DePuy ATTUNE INTUITION Impaction Handle Recalled for Fracture Risk

DePuy Orthopaedics is recalling ATTUNE INTUITION Impaction Handles because the lever can fracture during knee surgery, potentially leaving device pieces in the patient.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that could result in foreign objects being left in a patient, meeting the criteria for a Severe rating.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 7,944 units of the ATTUNE INTUITION Impaction Handle. This re-usable instrument is used in knee replacement procedures to impact, extract, and insert other surgical components. The recall is due to complaints indicating that the handle's lever has fractured during impaction.

If the lever fractures, there is a potential for fractured pieces of the device or the inner spring to be left in the patient if not observed during the surgery. The affected products were distributed worldwide, including the United States (nationwide except Alaska and Rhode Island, including Puerto Rico) and numerous international locations such as Canada, Australia, and the United Kingdom.

Healthcare providers should stop using the affected impaction handles and contact DePuy Orthopaedics for instructions on how to return the devices. The recall number is Z-0953-2015.

The recalled product

Product: The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial…
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Surgical Instrument
Hazard: structural-failure
foreign-object
Affected units: 7,944

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots Barcode GTIN: 10603295423324

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · DePuy Orthopaedics, Inc.

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